Today,
we are going to continue our series of hearings on vaccine policy.For the last few months, weve been focusing
on two important advisory committees.The Food and Drug Administration(FDA) and the Centers for Disease Control and Prevention (CDC) rely on
these advisory committees to help them make vaccine policies that affect every
child in this country.Weve looked
very carefully at conflicts of interest.Weve taken a good hard look at whether the pharmaceutical industry has
too much influence over these committees.From the evidence we found, I think they do.

The
first committee is the FDAs Vaccines and Related Biological Products Advisory
Committee (VRBPAC).This Committee
makes recommendations on whether new vaccines should be licensed.The second committee is the CDCs Advisory
Committee on Immunizations Practices (ACIP).This committee recommends which vaccines should be included on the
Childhood Immunization Schedule.

To
make these issues easier to understand, were going to focus on one issue
handled by these two committees  the Rotavirus vaccine.It was approved for use by the FDA in August
1998.It was recommended for universal
use by the CDC in March 1999.Serious
problems cropped up shortly after it was introduced.Children started developing serious bowel obstructions.The vaccine was pulled from the U.S. market
in October 1999.

So
the question is, was there evidence to indicate that the vaccine was not safe
and if so, why was it licensed in the first place?How good a job did the advisory committees do?Weve reviewed the minutes of the
meetings.At the FDAs committee, there
were discussions about adverse events.They were aware of potential problems.Five children out of 10,000 developed bowel obstructions.There were also concerns about children
failing to thrive and developing high fevers, which as we know from other
vaccine hearings, can lead to brain injury.Even with all of these concerns, the committee voted unanimously to
approve it.

At
the CDCs committee, there was a lot of discussion about whether the benefits
of the vaccine really justified the costs. Even though the cost-benefit ratio
was questioned, the Committee voted unanimously to approve it.

Were
they vigilant enough?Were they
influenced by the pharmaceutical industry?Was there appropriate balance of expertise and perspectives on vaccine
issues?Weve been reviewing their
financial disclosure statements.Weve
interviewed staff from the FDA and the CDC.The staff has prepared a staff report summarizing what weve found.At the end of my statement, Ill ask
unanimous consent to enter this report into the record.Weve identified a number of problems that
need to be brought to light and discussed.

Families
need to have confidence that the vaccines that their children take are safe,
effective, and truly necessary.Doctors
need to feel confident that when the FDA licenses a drug, that it is really
safe, and that the pharmaceutical industry has not influenced the decision-making
process.Doctors place trust in the FDA
and assume that if the FDA has licensed a drug, its safe to use.Has that trust been violated?

How
confident in the safety and need for specific vaccines would doctors and
parents be if they learned the following:

1.That members, including the Chair, of the FDA and CDC advisory
committees who make these decisions own stock in drug companies that make
vaccines.

2.That individuals on both advisory committees own patents for vaccines
under consideration or affected by the decisions of the committee.

3.That three out of five of the members of the FDAs advisory committee
who voted for the rotavirus vaccine had conflicts of interest that were
waived.

4.That seven individuals of the 15 member FDA advisory committee were not
present at the meeting, two others were excluded from the vote, and the
remaining five were joined by five temporary voting members who all voted to
license the product.

5.That the CDC grants conflict-of-interest waivers to every member of
their advisory committee a year at a time, and allows full participation in the
discussions leading up to a vote by every member, whether they have a financial
stake in the decision or not.

6.That the CDCs advisory committee has no public members  no parents
have a vote in whether or not a vaccine belongs on the childhood immunization
schedule.The FDAs committee only has
one public member.

These are
just a few of the problems we found.Specific examples of this include:

Dr. John ModlinHe served for four years on the CDC advisory
committee and became the Chair in February 1998.He participated in the FDAs committee as well owned stock in
Merck, one of the largest manufacturers of vaccines, valued at $26,000.He also serves on Mercks Immunization
Advisory Board.Dr. Modlin was the
Chairman of the Rotavirus working group.He voted yes on eight different matters pertaining to the ACIPs rotavirus
statement, including recommending for routine use and for inclusion in the
Vaccines for Children program.It was
not until this past year, that Dr. Modlin decided to divest himself of his
vaccine manufacturer stock.

At our April
6 autism hearing, Dr. Paul Offit disclosed that he holds a patent on a
rotavirus vaccine and receives grant money from Merck to develop this
vaccine.He also disclosed that he is
paid by the pharmaceutical industry to travel around the country and teach
doctors that vaccines are safe.Dr.
Offit is a member of the CDCs advisory committee and voted on three rotavirus
issues  including making the recommendation of adding the rotavirus vaccine to
the Vaccines for Childrens program.

Dr. Patricia Ferrieri, during her
tenure as Chair of the FDAs advisory committee, owned stock in Merck valued at
$20,000 and was granted a full waiver.

Dr. Neal Halsey, who serves as a
liaison member to the CDC committee on behalf of the American Association of
Pediatrics, and as a consultant to the FDAs committee, has extensive ties to
the pharmaceutical industry, including having solicited and received start up
funds from industry for his Vaccine Center.As a liaison member to the CDC committee, Dr. Halsey is there to
represent the opinions of the organization he represents, but was found in the
transcripts to be offering his personal opinion as well.

Dr. Harry Greenberg, who serves as
Chair of the FDA committee, owns $120,000 of stock in Aviron, a vaccine
manufacturer.He also is a paid member
of the board of advisors of Chiron, another vaccine manufacturer and owns
$40,000 of stock.This stock ownership
was deemed not to be a conflict and a waiver was granted.To the FDAs credit, he was excluded from
the rotavirus discussion because he holds the patent on the rotashield vaccine.

How
confident can we be in the process when we learned that most of the work of the
CDC advisory committee is done in working groups that meet behind closed
doors, out of the public eye?Members
who cant vote in the full committee because of conflicts of interest are
allowed to work on the same issues in working groups, and there is no public
scrutiny.I was appalled to learn that
at least six of the ten individuals who participated in the working group for
the rotavirus vaccine had financial ties to pharmaceutical companies developing
rotavirus vaccines.

How
confident can we be in the recommendations with the Food and Drug
Administration when the chairman and other individuals on their advisory
committee own stock in major manufacturers of vaccines?

How
confident can we be in a system when the agency seems to feel that the number
of experts is so few that everyone has a conflict and thus waivers must be
granted.It almost appears that there
is a old boys network of vaccine advisors that rotate between the CDC and FDA
 at times serving simultaneously.Some
of these individuals serve for more than four years.We found one instance where an individual served for sixteen
years continually on the CDC committee.With over 700,000 physicians in this country, how can one person be so
indispensable that they stay on a committee for 11 years?

It
is important to determine if the Department of Health and Human Services has
become complacent in their implementation of the legal requirements on
conflicts of interest and committee management.If the law is too loose, we need to change it.If the agencies arent doing their job, they
need to be held accountable.Thats the
purpose of this hearing, to try to determine what needs to be done.

Why
is this review necessary?Vaccines are
the only substances that a government agency mandates a United States citizen
receive.State governments have the
authority to mandate vaccines be given to children prior to admission to day
care centers and schools.State
governments rely on the recommendations of the CDC and the FDA to determine the
type and schedule of vaccines.

I am not
alone in my concern about the increasing influence of industry on
medicine.Last year, the New England Journal of Medicine learned
that 18 individuals who wrote drug therapy review articles had financial ties
to the manufacturer of the drugs discussed.The Journal, which has the most stringent conflict of interest
disclosures of medical journals, had a recent editorial discussing the
increasing level of academic research funded by the industry.The editor stated, What is at issue is not
whether researchers can be 'bought' in the sense of a quid pro quo, it is that close and remunerative collaboration with
a company naturally creates goodwill on the part of researchers and the hope
that the largesse will continue. This attitude can subtly influence scientific
judgment.

Can the FDA and the CDC really
believe that scientists are more immune to self-interest than other
people?

Maintaining
the highest level of integrity over the entire spectrum of vaccine development
and implementation is essential. The Department of Health and Human Services
has a responsibility to the American public to ensure the integrity of this
process by working diligently to appoint individuals that are totally without
financial ties to the vaccine industry to serve on these and all
vaccine-related panels.

No
individual who stands to gain financially from the decisions regarding vaccines
that may be mandated for use should be participating in the discussion or
policy making for vaccines.We have
repeatedly heard in our hearings that vaccines are safe and needed to protect
the public.If the panels that have
made the decisions on all vaccines on the Childhood Immunization Schedule had
as many conflicts as we found with rotavirus, then the entire process has been
polluted and the public trust has been violated.I intend to find out if the individuals who have made these
recommendations that effect every child in this country and around the world,
stood to gain financially and professionally from the decisions of the
committees they served on.

The
hearing record will remain open until June 28 for those who would like to
submit a statement into the hearing record.

Breaking News Archives- each day's breaking news from December 1, 2003
(check here for breaking news you might have missed and breaking news that
didn't ever hit the "front page")

DISCLAIMER: All
information, data, and material contained, presented, or provided here is for
general information purposes only and is not to be construed as reflecting the
knowledge or opinions of the publisher, and is not to be construed or intended
as providing medical or legal advice. The decision whether or not to vaccinate
is an important and complex issue and should be made by you, and you alone, in
consultation with your health care provider.

"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."

-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820

“A sacred cow will not protect the herd.”

-- Sandy Gottstein

"What's the point of vaccination if it doesn't protect you from the unvaccinated?"

-- Sandy Gottstein

"Who gets to decide what the greater good is and how many will be sacrificed to it?"